Atlas FDA

EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

FDA 510(k) clearance K080802 · decided 2008-04-30

Clearance details

K-number
K080802
Device name
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
2008-03-21
Decision date
2008-04-30
Days to decision
40 days
Clearance type
Special
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Palm Beach Gardens, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is recall (Z-1877-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device recall (Z-1878-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to b recall (Z-1879-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used recall (Z-1880-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used w recall (Z-1881-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only* recall (Z-1885-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is recall (Z-1886-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended recall (Z-1887-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device recall (Z-1888-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended recall (Z-1889-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is i recall (Z-1890-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used wi recall (Z-1891-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This d recall (Z-1892-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only recall (Z-1893-2014)The Anspach Effort, Inc.2014-06-25
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB recall (Z-0726-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM recall (Z-0727-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15D recall (Z-0728-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and recall (Z-0729-2014)The Anspach Effort, Inc.2014-01-13
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Syste recall (Z-0200-2014)The Anspach Effort, Inc.2013-11-13
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone i recall (Z-0074-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting recall (Z-0075-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usag recall (Z-0076-2013)The Anspach Effort, Inc.2012-10-18
Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trep recall (Z-0083-2010)The Anspach Effort, Inc.2009-10-28